Human Rights Measure

Human Rights
Human Rights

FDA Acting Commissioner Janet Woodcock has Notified ACOG [American College of Obstetricians and Gynecologists] and SMFM [Society for Maternal-Fetal Medicine] that the Agency will “Exercise Enforcement Discretion” Regarding Mifepristone though the Duration of the COVID19 Public Health Emergency

Date Enacted: April 2021
Country: United States
Region: North America

The Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) announced in a letter that it “intends to exercise enforcement discretion during the COVID-19 PHE [public health emergency] with respect to the in-person dispensing requirements of the Mifepristone REMS [Risk Evaluation and Mitigation Strategy] Program” and “to exercise enforcement discretion during the COVID-19 PHE with respect to the dispensing of mifepristone through the mail either by or under the supervision of a certified prescriber, or through mail-order pharmacy when such dispensing is done under the supervision of a certified prescriber.” The FDA’s determination was “effective immediately.” Subsequently, on December 16, 2021, the FDA announced “modifications to the Mifepristone REMS Program” consisting of the following: “[r]emoving the requirement that mifepristone be dispensed only in certain healthcare settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’)” and “[a]dding a requirement that pharmacies that dispense the drug be certified.”